Palliative CareNCT03181750
Apoyo Con Carino: Patient Navigation for Palliative Care for Non-Cancer Illness
A study testing Patient Navigator Intervention Group in people with Palliative Care, run by University of Colorado, Denver at 6 sites in United States.
Trial summary
Palliative care is a priority area of focus for the National Institute of Nursing Research. Despite the evidence-based benefits of palliative care, access remains limited, especially in poor urban and rural settings. Cultural and linguistic barriers may also increase disparities in palliative care for Latinos. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Palliative Care
- What is being tested?
- Patient Navigator Intervention Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 299 participants
- Where
- 6 sitesUnited States
- Study dates
- 2 Jun 2017to 31 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Self-identify as Latino
- Age 18-90 years
- Not referred or enrolled in hospice care
- Meeting medium to high risk for death at 1 year using the CARING criteria (although excluding patients with cancer diagnosis)
- OR
- If health care provider answers "no" to the question: "Would you be surprised if this patient died in the next year?"
Who cannot join
- Cancer diagnosis
- Referred or receiving hospice care
- Pregnant
- Incarcerated
- Lacking decisional capacity
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
University of Colorado Health Central
Aurora, Colorado, 80045
University of Colorado Health
Colorado Springs, Colorado, 80909
Centura Health
Denver, Colorado, 80112
Denver Health Medical Center
Denver, Colorado, 80204
Kaiser Permanente Colorado-N/S/W
Denver, Colorado, 80231
University of Colorado Health North
Fort Collins, Colorado, 80524
About this study
Official title: Apoyo Con Carino: (Support With Caring) Improving Palliative Care Outcomes for Latinos With Advanced Medical Illness
Palliative care is a priority area of focus for the National Institute of Nursing Research. Despite the evidence-based benefits of palliative care, access remains limited, especially in poor urban and rural settings. Cultural and linguistic barriers may also increase disparities in palliative care for Latinos. Due to a nationwide shortage of palliative care providers and the unique cultural preferences and values of patients, our innovative study has the potential to improve palliative care outcomes and reduce health disparities in both urban and rural underserved communities.
Read the detailed description
Latinos are more likely to experience uncontrolled pain, institutional death, and are less likely to engage in advance care planning. Efforts to increase access to palliative care must maximize primary palliative care and community based models to meet the ever growing need in a culturally-sensitive and congruent manner. Patient navigator interventions are community based, culturally tailored models of care and have been successfully implemented to improve disease prevention, early diagnosis and treatment. The investigators have developed and implemented a patient navigation intervention to improve palliative care outcomes for seriously ill hospitalized Latinos. They have demonstrated feasibility and early findings suggest this intervention can improve palliative care outcomes for Latinos with advanced cancer. Building on this prior research, the investigators propose a fully powered randomized controlled trial to determine the effectiveness of the manualized patient navigator intervention in a non-cancer population. A total of 240 Latino adults with non-cancer, advanced medical illness enrolled from 8 urban and 4 rural clinical sites will be randomized to the intervention group (5 palliative care-related patient navigator visits plus educational materials) or control group (usual care plus educational materials). Participants randomized to the intervention group will demonstrate better quality of life, will be more likely to have a palliative approach to their care, have higher rates of advance care planning, better pain and symptom control, and higher rates of hospice utilization compared to the control group). They will conduct a cost analysis of the patient navigator intervention by comparing direct costs of the intervention and cost and utilization of health care system resources across the study arms. Participants randomized to the intervention will have lower costs in the 6 months following study enrollment compared to participants in the control arm. Decedent participants randomized to the intervention will have lower costs in the last 3 months of life compared to decedent participants in the control arm. For the intervention visits, bicultural, bilingual navigators (guias) integrate core Latino values, while addressing barriers to a palliative approach through education, culturally tailored messaging, and patient activation. Patients will be interviewed at baseline and 3 months using the QUAL-E quality of life scale, Brief Pain Inventory, Edmonton Symptom Assessment Scale, and the Patient Navigator Process and Outcomes Measure. Medical records will be reviewed to assess advance directive completion, hospice and health care utilization and intensity of care at the end of life. This culturally tailored, evidence-based, theory driven, highly innovative patient navigation intervention has significant potential to improve palliative care for Latinos, and facilitate true health equity in palliative and end of life care.
- Conditions
- Palliative Care
- Being tested
- Patient Navigator Intervention Group
- Keywords
- Palliative Care, Latino, Patient Navigation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient Navigator Intervention GroupBehavioural
Bicultural, bilingual navigators conducting home visits with patients and caregivers.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Patients and caregivers randomized to this arm will receive a packet of educational materials in English or Spanish. These materials are written at 5-6th grade reading level. The materials focus on advance care planning, pain and symptom management, and hospice care. |
| Patient Navigator Intervention Group | Experimental | Patient and caregivers randomized to this arm will receive the same packet of educational materials. They will also receive at least 5 visits from a bicultural bilingual patient navigator. The navigator will utilize a annualized visit guide manual to lead discussions on advance care planning, pain and symptom management, and hospice care. Receives: Behavioral: Patient Navigator Intervention Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
FACIT-Quality of Life Assessment
Validated and responsive Quality of Life measure
Measured: 3 months post enrollment
Caregiver Reaction Assessment
For caregivers: A validated measure of caregiver burden and positive meaning finding for caregivers
Measured: 3 months post enrollment
Secondary outcomes (6)
Brief Pain Inventory
A validated pain assessment measure
Measured: 3 months post enrollment
Edmonton Symptom Assessment Scale
A validated symptom assessment scale
Measured: 3 months post enrollment
Patient Navigation Process and Outcome Measure
A satisfaction and process measure developed for the patient navigator intervention
Measured: 3 months post enrollment
Advance Care Planning
chart review to document presence of advance directive
Measured: 6 months post enrollment
Hospice Utilization
hospice length of stay in days
Measured: month 46 of the study
Advance Care Planning Engagement Survey
A validated measure of readiness to engage in advance care planning
Measured: 3 months post enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2017
- Study start2 Jun 2017
- Primary completion9 Dec 2020
- Study completion31 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Palliative CareStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multi-site Randomized Controlled Trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 299 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Kaiser Permanente, Denver Health Medical Center, National Institute of Nursing Research (NINR)
- Responsible party
- Sponsor
- Investigators
- Stacy M Fischer, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03181750
- Sponsor's protocol ID
- 16-1270
- Other IDs
- R01NR016467
- Status last verified
- Apr 2022
- First submitted
- 5 Jun 2017
- Last updated
- 19 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fischer SM, Min SJ, Kline DM, Lester K, Gozansky W, Schifeling C, Himberger J, Lopez J, Fink RM. Patient Navigator Intervention to Improve Palliative Care Outcomes for Hispanic Patients With Serious Noncancer Illness: A Randomized Clinical Trial. JAMA Intern Med. 2024 Apr 1;184(4):384-393. doi: 10.1001/jamainternmed.2023.8145.
PubMed 38345793Fink RM, Valenti KG, Kline DM, Fischer SM. Reality of Family Caregiving for Hispanics With Alzheimer's Disease and Related Dementias: A Qualitative Analysis. J Palliat Med. 2023 Dec;26(12):1618-1626. doi: 10.1089/jpm.2023.0008. Epub 2023 Jun 13.
PubMed 37311202
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Apoyo Con Carino: (Support With Caring) Improving Palliative Care Outcomes for Latinos With Advanced Medical Illness
- ClinicalTrials.gov ID
- NCT03181750
- Acronym / sponsor ID
- 16-1270
- Conditions
- Palliative Care
- Keywords
- Palliative Care, Latino, Patient Navigation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 299 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Kaiser Permanente, Denver Health Medical Center, National Institute of Nursing Research (NINR)
- Study start
- 2 Jun 2017 (actual)
- Primary completion
- 9 Dec 2020 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 9 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Palliative care is a priority area of focus for the National Institute of Nursing Research. Despite the evidence-based benefits of palliative care, access remains limited, especially in poor urban and rural settings. Cultural and linguistic barriers may also increase disparities in palliative care for Latinos. Due to a nationwide shortage of palliative care providers and the unique cultural preferences and values of patients, our innovative study has the potential to improve palliative care outcomes and reduce health disparities in both urban and rural underserved communities.
Detailed description
Latinos are more likely to experience uncontrolled pain, institutional death, and are less likely to engage in advance care planning. Efforts to increase access to palliative care must maximize primary palliative care and community based models to meet the ever growing need in a culturally-sensitive and congruent manner. Patient navigator interventions are community based, culturally tailored models of care and have been successfully implemented to improve disease prevention, early diagnosis and treatment. The investigators have developed and implemented a patient navigation intervention to improve palliative care outcomes for seriously ill hospitalized Latinos. They have demonstrated feasibility and early findings suggest this intervention can improve palliative care outcomes for Latinos with advanced cancer. Building on this prior research, the investigators propose a fully powered randomized controlled trial to determine the effectiveness of the manualized patient navigator intervention in a non-cancer population. A total of 240 Latino adults with non-cancer, advanced medical illness enrolled from 8 urban and 4 rural clinical sites will be randomized to the intervention group (5 palliative care-related patient navigator visits plus educational materials) or control group (usual care plus educational materials). Participants randomized to the intervention group will demonstrate better quality of life, will be more likely to have a palliative approach to their care, have higher rates of advance care planning, better pain and symptom control, and higher rates of hospice utilization compared to the control group). They will conduct a cost analysis of the patient navigator intervention by comparing direct costs of the intervention and cost and utilization of health care system resources across the study arms. Participants randomized to the intervention will have lower costs in the 6 months following study enrollment compared to participants in the control arm. Decedent participants randomized to the intervention will have lower costs in the last 3 months of life compared to decedent participants in the control arm. For the intervention visits, bicultural, bilingual navigators (guias) integrate core Latino values, while addressing barriers to a palliative approach through education, culturally tailored messaging, and patient activation. Patients will be interviewed at baseline and 3 months using the QUAL-E quality of life scale, Brief Pain Inventory, Edmonton Symptom Assessment Scale, and the Patient Navigator Process and Outcomes Measure. Medical records will be reviewed to assess advance directive completion, hospice and health care utilization and intensity of care at the end of life. This culturally tailored, evidence-based, theory driven, highly innovative patient navigation intervention has significant potential to improve palliative care for Latinos, and facilitate true health equity in palliative and end of life care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Multi-site Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Patients and caregivers randomized to this arm will receive a packet of educational materials in English or Spanish. These materials are written at 5-6th grade reading level. The materials focus on advance care planning, pain and symptom management, and hospice care. |
| Patient Navigator Intervention Group | Experimental | Behavioral: Patient Navigator Intervention GroupPatient and caregivers randomized to this arm will receive the same packet of educational materials. They will also receive at least 5 visits from a bicultural bilingual patient navigator. The navigator will utilize a annualized visit guide manual to lead discussions on advance care planning, pain and symptom management, and hospice care. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Self-identify as Latino
- Age 18-90 years
- Not referred or enrolled in hospice care
- Meeting medium to high risk for death at 1 year using the CARING criteria (although excluding patients with cancer diagnosis)
- OR
Key exclusion criteria (5 listed)
- Cancer diagnosis
- Referred or receiving hospice care
- Pregnant
- Incarcerated
- Lacking decisional capacity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient Navigator Intervention GroupBicultural, bilingual navigators conducting home visits with patients and caregivers. | Behavioural | Patient Navigator Intervention Group |
Primary outcome
FACIT-Quality of Life Assessment
Time frame: 3 months post enrollment
Validated and responsive Quality of Life measure
Caregiver Reaction Assessment
Time frame: 3 months post enrollment
For caregivers: A validated measure of caregiver burden and positive meaning finding for caregivers
6 secondary outcomes
Brief Pain Inventory
Time frame: 3 months post enrollment
Edmonton Symptom Assessment Scale
Time frame: 3 months post enrollment
Patient Navigation Process and Outcome Measure
Time frame: 3 months post enrollment
Advance Care Planning
Time frame: 6 months post enrollment
Hospice Utilization
Time frame: month 46 of the study
Advance Care Planning Engagement Survey
Time frame: 3 months post enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2022.
- Derived from this study: PubMed 38345793Fischer SM, Min SJ, Kline DM, Lester K, Gozansky W, Schifeling C, Himberger J, Lopez J, Fink RM. Patient Navigator Intervention to Improve Palliative Care Outcomes for Hispanic Patients With Serious Noncancer Illness: A Randomized Clinical Trial. JAMA Intern Med. 2024 Apr 1;184(4):384-393. doi: 10.1001/jamainternmed.2023.8145.
- Derived from this study: PubMed 37311202Fink RM, Valenti KG, Kline DM, Fischer SM. Reality of Family Caregiving for Hispanics With Alzheimer's Disease and Related Dementias: A Qualitative Analysis. J Palliat Med. 2023 Dec;26(12):1618-1626. doi: 10.1089/jpm.2023.0008. Epub 2023 Jun 13.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stacy M Fischer, MD principal investigator
University of Colorado, Denver
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient Navigator Intervention Group in people with Palliative Care, run by University of Colorado, Denver at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FACIT-Quality of Life Assessment (time frame: 3 months post enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03181750, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2022.